Effect of Enterococcus Faecium and Bacillus Subtilis-Containing Multispecies Probiotic Supplementation on the Therapeutic Efficacy of Rifaximin α in Patients With Small Intestinal Bacterial Overgrowth (SIBO): a Prospective, Randomized, Placebo-controlled Trial
试验速览
- 阶段
- 4 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 100
- 主要终点
- SIBO eradication rate
研究概览
简要总结
Small intestinal bacterial overgrowth (SIBO) is a common condition associated with gastrointestinal symptoms such as bloating, abdominal pain, diarrhea, and constipation, particularly in patients with irritable bowel syndrome. Antibiotic therapy with rifaximin is commonly used, but relapse rates remain high.
This randomized, placebo-controlled clinical trial aims to evaluate whether supplementation with a multispecies probiotic containing Enterococcus faecium and Bacillus subtilis improves the effectiveness of rifaximin therapy in adult patients with SIBO.
Participants will be randomly assigned to receive either rifaximin plus the probiotic or rifaximin plus placebo. Clinical assessments will include hydrogen breath testing and evaluation of gastrointestinal symptoms using standardized questionnaires at baseline and during follow-up visits.
The study is being conducted at a single academic medical center in Poland and is sponsored by Państwowy Instytut Medyczny MSWiA. The probiotic and rifaximin are provided by Urgo.
The results of this study may help determine whether probiotic supplementation can improve treatment outcomes and reduce recurrence of SIBO.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age ≥18 years.
- •Meets Rome IV criteria for irritable bowel syndrome.
- •Written informed consent to participate in the study.
排除标准
- •Lack of cooperation with investigators.
- •Age >75 years.
- •Need for modification of gastrointestinal treatment during the study.
- •Use of antibiotics within 4 weeks before screening.
- •Use of probiotics within 7 days before screening.
- •Endoscopic examination within 6 weeks before screening or during the study without investigator approval.
- •History of abdominal surgery.
- •Crohn's disease, ulcerative colitis, microscopic colitis, celiac disease, cystic fibrosis, chronic pancreatitis, liver cirrhosis, or end-stage renal disease.
- •Low FODMAP diet within 4 weeks before screening.
- •Pregnancy or breastfeeding.
- •Lactulose intolerance.
研究组 & 干预措施
Probiotic Group
Participants will receive rifaximin followed by the probiotic preparation according to the study protocol.
干预措施: Probiotic preparation (Dietary Supplement)
Probiotic Group
Participants will receive rifaximin followed by the probiotic preparation according to the study protocol.
干预措施: Rifaximin (drug) (Drug)
Placebo Group
Participants will receive rifaximin followed by placebo according to the study protocol.
干预措施: Placebo (Other)
Placebo Group
Participants will receive rifaximin followed by placebo according to the study protocol.
干预措施: Rifaximin (drug) (Drug)
结局指标
主要结局
SIBO eradication rate
时间窗: 4 weeks
Proportion of participants with eradicated small intestinal bacterial overgrowth (SIBO), defined as a negative hydrogen breath test, assessed 4 weeks after treatment initiation (rifaximin for 14 days plus probiotic for 4 weeks).
次要结局
- SIBO recurrence rate after completion of probiotic therapy(10 weeks)